Topical 2% cyclosporine A in preservative-free artificial tears for the treatment of vernal keratoconjunctivitis

Abstract

Background: A double-masked, placebo-controlled trial to evaluate the short-term efficacy and safety of topical 2% cyclosporine A in preservative-free artificial tears for patients with vernal keratoconjunctivitis.

Methods: Twenty patients with severe vernal keratoconjunctivitis were included in the study. All were treated with topical 2% cyclosporine A eye drops. One eye of each patient was administered 2% cyclosporine A in preservative-free artificial tears; the fellow eye received the placebo (vehicle) for the first 2 weeks, in a double-masked, placebo-controlled trial. Thereafter, the placebo eye received cyclosporine A (open trial). Symptoms and signs were scored on the day of enrollment and at the end of week 2, 4, and 14.

Results: At the end of week 2, no statistically significant decrease was noted from baseline in mean scores of either signs (p = 0.18) or symptoms (p = 0.50) in the eyes that received placebo. On the other hand, a statistically significant decrease was observed in both sign and symptom scores (p < 0.001, for both) of eyes that received cyclosporine A. Significant differences were also noted at 2 weeks in mean scores of both signs and symptoms (p < 0.001, for both) between the eyes that received cyclosporine A and those that received placebo. At week 4 and 14, statistically significant decreases in both sign scores and symptom scores were noted compared with baseline in the eyes that received cyclosporine A and in the eyes that had initially received placebo (p < 0.001, for all).

Interpretation: Topical 2% cyclosporine A in preservative-free artificial tears is effective in alleviating signs and symptoms of patients with severe vernal keratoconjunctivitis and had no observed side effects over the course of the study.